top of page
Case Studies & Blogs
Two regulators, two data frameworks. One target trial specification.
FDA and EMA assess RWE feasibility differently. Learn how the target trial framework bridges fit-for-purpose and DARWIN EU for multi-jurisdictional studies.
Mar 256 min read
The two-trial era may be over. The hard part isn't.
FDA's default is now a single pivotal trial plus confirmatory evidence. Such evidence requires rigour. We advocate that target trial framework provides this rigour.
Mar 115 min read
EU JCA is here. Rare diseases are next. Your RWD strategy can’t wait.
EU JCA will include rare diseases from 2028. Target trial framework provides a path to incorporating real world data into strategic thinking in preparation for EU JCA inclusion.
Feb 163 min read
bottom of page